BOTSWANA: Tenofovir trials to start soon - despite controversy
[This report does not necessarily reflect the views of the United Nations]
GABORONE, 30 March (PLUSNEWS) - Botswana will soon be embarking on the clinical trials of the anti-AIDS drug, tenofovir, despite concerns over how the tests were conducted in Cameroon, Nigeria and Cambodia.
The antiretroviral drug, manufactured by US pharmaceutical company Gilead and sold under the brand name, 'Viread', will be tested as a possible prophylactic to prevent people becoming infected with the HI virus.
Similar HIV prevention trials of tenofovir, run by Family Health International, have been dogged by controversy. In March Nigeria became the third country after Cambodia and Cameroon to have the tests suspended, when doubts were raised about local trial procedures.
Earlier this year, activists in France and Cameroon launched protests over the treatment of sex workers participating in the experiments, claiming that the women had not been sufficiently informed of the risks involved.
Widespread negative publicity on the issue elicited fears that people in the developing world were being exploited for scientific research.
The Botswana tests, sponsored by the US Centres for Disease Control and Prevention (CDC), "will not start until ethics committees in the Ministry of Health and at CDC are satisfied that we have in place all the necessary ethical safeguards and procedures", said Gregory Kelebonye, the Communication Manager of BOTUSA, an HIV/AIDS partnership between the government of Botswana and the CDC.
Kelebonye admitted that the problems encountered in the other countries had forced BOTUSA to be "extremely careful", and said the partnership had been meeting with various HIV/AIDS stakeholders in Gaborone, the capital, and Francistown, Botswana's second city, for over a year to iron out any concerns.
Community advisory boards made up of community members, local NGOs and government representatives have been established to monitor the trials and mobilise the community; participant advisory boards will also be set up when the trials begin.
"We have incorporated the fears raised in Cameroon ... to make sure that sort of thing never happens here, and right now we are very satisfied that the processes are in place to make sure the participants are protected," Kasule Kibirige, chairman of the Gaborone community advisory group, told PlusNews.
Activists in Southern Africa will be closely following the trials to ensure that internationally accepted ethical standards in biomedical research are not being breached in the country with one of the world's highest infection rates.
Even members of Botswana's parliament have been targeted, Kelebonye noted. "We would like everybody to come on board and make this as transparent as we can."
CDC is sponsoring three clinical trials of the drug among three populations at high risk of infection: heterosexuals in Botswana, intravenous drug users in Thailand, and men who have sex with men in the US.
The three sites will assess the effects of taking a daily pill on HIV risk behaviour; adherence to, and acceptability of, the regimen; and, in cases where participants become HIV infected, the resistance characteristics of the acquired virus.
In Botswana about 1,200 HIV-negative sexually active men and women from Gaborone and Francistown will be involved in the experiment.
The participants will be recruited through voluntary counselling and testing centres, clinics, youth organisations and community events. Education programmes are to be carried out via multimedia programmes in English and Setswana.
Kelebonye pointed out that the purpose of the tests was not to get the participants infected with the HI virus, and they would be provided with extensive counselling at each study visit, free male and female condoms, with STD testing and treatment to reduce their risk of becoming infected.
According to the CDC fact sheet on the trials, participants who become infected will receive "confirmatory testing for infection, post-test risk-reduction and support counselling, and help enrolling in local HIV care programmes. Both Thailand and Botswana have antiretroviral treatment and HIV care programmes in place at minimal or no cost to patients."
"Our foremost concern is that the health of the participants should not be in any jeopardy for the sake of research," Kibirige confirmed.
Laboratory testing of tenofovir on monkeys had proved successful in preventing them from contracting the simian version of HIV, paving the way for human trials on the use of tenofovir as a prophylactic, which began last year.
Despite the suspension in Cambodia, Cameroon and Nigeria, these trials are still underway in Ghana and among males from the gay communities of Atlanta and San Francisco in the United States.
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